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Associate Clinical Data Manager

8-10 years
Preferred by Comapny
10 Nov. 24, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Data Manager (Lead)

Location: Bangalore, India / Remote (India)
Time Type: Full Time
Posted On: 4 Days Ago
End Date to Apply: December 2, 2024 (6 days left to apply)
Job Requisition ID: 2427808


Company Overview

Fortrea is a global contract research organization (CRO) committed to scientific rigor with decades of clinical development experience. We provide clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients globally.


Key Responsibilities

  • Collaboration & Reporting: Work closely with the Lead Data Manager (LDM) to ensure effective project management, including multi-site studies and a combination of healthy and patient populations. Provide functional support to the LDM, ensuring adherence to timelines, protocols, and quality standards.

  • Data Review & Query Management: Lead the review of study data, ensuring quality control and query management for data accuracy, and ensuring compliance with internal and sponsor standards.

  • Study Milestone Timelines: Collaborate with the LDM to build and monitor study timelines, ensuring all deliverables are completed on time. Suggest improvements when necessary for study design and timelines.

  • Documentation & Trial Data Management: Assist in writing, updating, reviewing, and approving all trial data management documentation, including:

    • Study-specific case report forms (CRFs)
    • CRF Completion Guidelines
    • Data Management Plan (DMP)
    • Data Quality Checks (edit checks)
  • Operational Support: Manage data transfer agreements, track scope changes, ensure proper documentation during project completion, and assist with internal or external meetings and audits. Provide reports to sponsors as needed.

  • Quality Control & Compliance: Ensure data quality and integrity through regular QC checks, assisting in the completion of Database Lock and Unlock activities.

  • Training & Team Support: Assist in training new team members, ensuring service quality aligns with the DMP and scope of work.

  • Customer Relations: Support customer satisfaction by addressing client concerns and ensuring timely and quality delivery of data.


Qualifications & Experience

  • Educational Qualifications:

    • University/college degree in Life SciencesHealth SciencesInformation Technology, or related fields.
    • Relevant experience can be accepted in lieu of a degree.
  • Experience:

    • Minimum 8 to 10 years of experience in Data Management (DM), preferably in the clinical trial process.
    • Previous experience with Scope of Work and budget management is preferred.
  • Skills & Competencies:

    • Proficiency in time management and project productivity metrics.
    • Strong organizational, communication, and interpersonal skills.
    • Ability to collaborate effectively within a team environment.
    • Medical terminology knowledge is a plus.
    • Ability to manage clinical trial processes and work within clinical operations, biometrics, and system applications.

Why Join Fortrea?

Fortrea is committed to revolutionizing clinical trials and accelerating life-changing therapies to patients worldwide. If you're a motivated problem-solver passionate about making a global impact, we invite you to apply and become part of our exceptional team.


Fortrea is an Equal Opportunity Employer:
We encourage diversity and inclusion and do not tolerate harassment or discrimination of any kind. We base employment decisions on business needs and individual qualifications, fostering an inclusive workplace for all.

For more information about Fortrea, visitwww.fortrea.com